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Recall Observatory FDA recall evidence

Device product

RENASYS EDGE 800ML CANISTER WITH Solidifier- Indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing Product Number: 66803140

Z-1597-2024

March 11, 2024

Class II

Product summary

Firm
Smith & Nephew Medical, Ltd.
Event
Event 94248
Status
Ongoing
Classification
Class II
Quantity
675 units
Official record key
device-enforcement:Z-1597-2024

Official wording

Reason: Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump

Code information: GTIN: (01)05000223501082 Lot Numbers: 1016051, 1017549

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Chile.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    particulate matter